In vitro diagnostic medical devices: From the IVDD Directive to the IVDR Regulation

The IVD Regulation IVDR holds many innovations for medical device manufacturers. Our free template "The Technical Documentation under the IVDR" supports you in adapting your product file.

Due to their specificity, IVDs are regulated separately: in the In vitro Diagnostic Device Regulation, IVDR (EU) 2017/74, valid from May 26, 2022; and until now via Directive IVDD 98/79/EC.

With the Technical Documentation, you as a manufacturer prove the conformity of your IVD with the underlying regulations of the individual countries. Since the IVDR brings with it many innovations, it is essential for you as an IVD manufacturer to quickly take care of the adaptation of your technical documentation.

We are now making the IVDR innovations available to you free of charge as a PDF download. Use our whitepaper "Technical Documentation under the IVDR" as a template and checklist for your IVDR adaptation!

Classification of IVDs

Under the IVD Directive, products are classified according to Annex II as List A or B products, or as products for self-testing and others. New with the introduction of the IVDR regulation is a classification based on seven classification rules into classes A, B, C or D. Depending on the classification of the IVD, different requirements for the conformity assessment procedure and the involvement of the notified body must be observed. More about Classification of IVDs

IVDR: What are the new requirements?

UDI, EUDAMED, software, classification, involvement of Notified Bodies for a large part of the devices... These are some buzzwords from the current discussion and, with a view to the entry into force of the IVDR, the biggest challenges you will face as a manufacturer. In addition, these topics are interdependent, i.e. the results of risk management influence software development, UDI requirements influence the labeling processes, and the requirements for post-market surveillance must be mapped in the QMS. Have you already developed a suitable strategy for this?

A concrete calculation example: If you need 200 working hours each for the revision of 50 product files, that's a total of 10,000 hours of working time. Who in your team can do that?

We are happy to support you and look forward to contributing to your team's success!.
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Your advantages when working with us

  • We are your reliable partner for adapting your QM processes and developing and revising the technical documentation of your IVDs.
  • You receive all documents for your technical documentation based on your templates and ready to be signed for approval (international) or product certification (EU).
  • Our experience with technical documentation and the certification process as well as with verification and validation ensures that we reach your goals quickly and efficiently.
  • Our GAP analyses deliver recommendations on all levels of your regulatory activities (QM system, technical documentation, product portfolio).

Our services in detail

Develop and maintain the technical documentation
  • Creating the content of the technical documentation (EU and international) – conforming to applicable standards and laws,
  • Checking the technical documentation of IVDs already available on the market against current regulatory requirements,
  • Communicating with notified bodies and test laboratories.

Revising and adapting quality management
  • Analyzing the need for changes,
  • Adapting the processes.

In addition we offer consulting and support for:
  • Risk management process in accordance with ISO 14971,
  • Usability in accordance with ISO 62366,
  • Software development process in accordance with IEC 62304,
  • Performance evaluation, verification and validation.

Keep track of everything: Your IVDR schedule

IVD classification: Everything planned already?

Especially the new classification rules and the resulting increase in regulation through the notified body confront manufacturers with tremendous challenges. Considering the defined timelines, you need a solid and elaborate plan how to revise the technical documentation.

More of what we can do for you and your technical documentation